Download Radiofrequency Ablation of the Renal Nerves as a

Corporate Medical Policy
Radiofrequency Ablation of the Renal Nerves as a Treatment of
Hypertension
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radiofrequency_ablation_of_the_renal_nerves_as_a_treatment_of_hypertension
10/2012
4/2017
4/2018
4/2017
Description of Procedure or Service
Resistant Hypertension.
Hypertension is a widely prevalent condition, which is estimated to affect approximately 30% of
the population in the United States. It accounts for a high burden of morbidity related to strokes,
ischemic heart disease, kidney disease, and peripheral arterial disease. Resistant hypertension is
defined as elevated blood pressure (BP) despite treatment with at least 3 antihypertensive agents
at optimal doses. Resistant hypertension is also a relatively common condition, given the large
number of individuals with hypertension. In large clinical trials of hypertension treatment, up to
20-30% of participants meet the definition for resistant hypertension, and in tertiary care
hypertension clinics, the prevalence has been estimated to be 11-18%. Resistant hypertension is
associated with a higher risk for adverse outcomes such as stroke, myocardial infarction (MI),
heart failure, and kidney failure.
There are a number of factors that may contribute to uncontrolled hypertension, and these should
be considered and addressed in all patients with hypertension prior to labeling a patient resistant.
These include non-adherence to medications, excessive salt intake, inadequate doses of
medications, excess alcohol intake, volume overload, drug-induced hypertension, and other forms
of secondary hypertension. Also, sometimes it is necessary to address co-morbid conditions, i.e.,
obstructive sleep apnea, in order to adequately control BP.
Treatment for resistant hypertension is mainly intensified drug therapy, sometimes with the use
of non-traditional antihypertensive medications such as spironolactone and/or minoxidil.
However, control of resistant hypertension with additional medications is often challenging and
can lead to high costs and frequent adverse effects of treatment. As a result, there is a large
unmet need for additional treatments that can control resistant hypertension. Non-pharmacologic
interventions for resistant hypertension include modulation of the baroreflex receptor, and/or
radiofrequency (RF) denervation of the renal nerves.
Radiofrequency Denervation of the Renal Sympathetic Nerves.
Increased sympathetic nervous system activity has been linked to essential hypertension. Surgical
sympathectomy has been shown to be effective in reducing blood pressure but is limited by the
adverse side effects of surgery and was largely abandoned after effective medications for
hypertension became available. The renal sympathetic nerves arise from the thoracic nerve roots
and innervate the renal artery, the renal pelvis, and the renal parenchyma. Radiofrequency
ablation (RFA) is thought to decrease both the afferent sympathetic signals from the kidney to the
brain and the efferent signals from the brain to the kidney. This decreases sympathetic activation,
decreases vasoconstriction, and decreases activation of the renin-angiotensin system.
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An Independent Licensee of the Blue Cross and Blue Shield Association
Radiofrequency Ablation of the Renal Nerves as a Treatment of
Hypertension
The procedure is performed percutaneously with access at the femoral artery. A flexible catheter
is threaded into the renal artery and controlled; low-power RF energy is delivered to the arterial
walls where the renal sympathetic nerves are located. Once adequate RF energy has been
delivered to ablate the sympathetic nerves, the catheter is removed.
Regulatory Status
No RFA devices have been approved by the U.S. Food and Drug Administration (FDA) for
ablation of the renal sympathetic nerves as a treatment for hypertension. There are several
devices that have been developed for this purpose and are in various stages of application for
FDA approval.
•
•
The Symplicity™ Renal Denervation System (Medtronic, Minneapolis, MN)
The EnligHTN™ Multi-Electrode Renal Denervation System (St. Jude Medical,
Plymouth, MN) is an RFA catheter using a 4-point multiablation basket design. In
January 2014, the EnligHTN™ Renal Guiding Catheter was cleared for marketing by
FDA through the 510(k) process based on substantial equivalence to predicate devices
for the following indication: percutaneous use through an introducer sheath to facilitate a
pathway to introduce interventional and diagnostic devices into the renal arterial
vasculature.
• The One-Shot Renal Denervation System™ (Covidien, Dublin) is an irrigated RFA
balloon
catheter, consisting of a spiral shaped electrode surrounding a balloon. In January, 2014,
Covidien abandoned development of its OneShot™ Renal Denervation.
• The Vessix™ Renal Denervation System (Boston Scientific, Marlborough, MA; formerly
the V2 renal denervation system, Vessix Vascular) is a combination of a RF balloon
catheter and bipolar RF generator technologies, intended to permit a lower voltage
intervention.
Other RFA catheters (eg, Thermocouple Catheter™ (Biosense Webster, Diamond Bar, CA)
used for other types of ablation procedures (eg, cardiac electrophysiology procedures) have
been used off-label for RFA of the renal arteries.
.
***Note: This Medical Policy is complex and technical. For questions concerning the technical
language and/or specific clinical indications for its use, please consult your physician.
Policy
Radiofrequency ablation of the renal sympathetic nerves is considered investigational. BCBSNC
does not provide coverage for investigational services or procedures.
Benefits Application
This medical policy relates only to the services or supplies described herein. Please refer to the
Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit
design; therefore member benefit language should be reviewed before applying the terms of this
medical policy.
When Radiofrequency Ablation of the Renal Nerves is covered
Not applicable.
When is Radiofrequency Ablation of the Renal Nerves not covered
Radiofrequency ablation of the renal sympathetic nerves is considered investigational for
treatment of resistant hypertension.
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An Independent Licensee of the Blue Cross and Blue Shield Association
Radiofrequency Ablation of the Renal Nerves as a Treatment of
Hypertension
Policy Guidelines
The evidence for the use of radiofrequency ablation (RFA) of the renal sympathetic nerves for
individuals with resistant hypertension includes at least 10 randomized controlled trials (RCTs),
along with multiple nonrandomized comparative studies and case series. Relevant outcomes are
symptoms, change in disease status, morbid events, medication use, and treatment-related
morbidity. The largest trial, the Symplicity HTN-3 trial, which used a sham-controlled design to
reduce the likelihood of placebo effect, demonstrated no significant differences between renal
denervation and sham-control patients in office based or ambulatory blood pressure at 6-month
follow-up. The Symplicity HTN-3 results are supported by a subsequent sham-controlled trial.
The Symplicity HTN-3 results were in contrast to additional studies, including Symplicity HTN-2
and DENERHTN, which reported efficacy in reducing blood pressure over a 6-month time period
compared with a control group. Additional smaller RCTs, some of which were stopped early after
results of the Symplicity HTN-3 trial became available, did not demonstrate significantly
improved outcomes with renal denervation. Single-arm studies with overlapping populations
report improvements in blood pressure and related physiologic parameters, such as
echocardiographic measures of left ventricular hypertrophy, that appear to be durable up to 24
months of follow-up. The body of evidence for the use of renal denervation to treat hypertension
consists of RCTs that have conflicting results. The strongest evidence comes from shamcontrolled trials, the largest of which found no significant benefits with renal denervation. The
evidence is insufficient to determine the effects of the technology on health outcomes.
Billing/Coding/Physician Documentation Information
This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that
it will be reimbursed. For further information on reimbursement guidelines, please see Administrative
Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed
in the Category Search on the Medical Policy search page.
Applicable service codes: 0338T, 0339T
BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of
support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to
make a medical necessity determination is included.
Scientific Background and Reference Sources
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.136, 8/9/12
National Institutes of Health (NIH). Clinical trial #NCT01418261. Renal Denervation in Patients
With Uncontrolled Hypertension (SYMPLICITY HTN-3). Retrieved from
http://clinicaltrials.gov/ct2/show/NCT01418261?term=NCT01418261&rank=1
Doumas M, Papademetriou V, Douma S et al. Benefits from treatment and control of patients
with resistant hypertension. Int J Hypertens 2010; 2011:318549. Retrieved from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3014695/
Thomas G, Shishehbor MH, Bravo EL, Nally JV. Renal denervation to treat resistant
hypertension: Guarded optimism. Cleve Clin J Med. 2012 Jul;79(7):501-10. Retrieved from
http://www.ccjm.org/content/79/7/501.long
Schlaich MP, Hering D, Sobotka P, Krum H, et al., Effects of renal denervation on sympathetic
activation, blood pressure, and glucose metabolism in patients with resistant hypertension. Front
Physiol. 2012;3:10. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3270497/
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An Independent Licensee of the Blue Cross and Blue Shield Association
Radiofrequency Ablation of the Renal Nerves as a Treatment of
Hypertension
Bunte MC, Infante de Oliveira E, Shishehbor MH. Endovascular Treatment of Resistant and
Uncontrolled Hypertension, Therapies on the Horizon. J Am Coll Cardiol Intv. 2013;6(1):1-9.
Retrieved from http://interventions.onlinejacc.org/article.aspx?articleid=1487128#topLocation
National Institutes of Health (NIH). Clinical trial #NCT01541865. Treatment of Resistant
Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
(REDUCE-HTN). Retrieved from
http://clinicaltrials.gov/ct2/show/NCT01541865?term=REDUCE-HTN&rank=1
National Institutes of Health (NIH). Clinical trial #NCT01438229. Safety and Efficacy Study of
Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN I). Retrieved from
http://clinicaltrials.gov/ct2/show/NCT01438229
Medical Director review 3/2013
Specialty Matched Consultant Advisory Panel review 4/2013
Lambert GW, Hering D, Esler MD et al. Health-related quality of life after renal denervation in
patients with treatment-resistant hypertension. Hypertension 2012; 60(6):1479-84.
Ott C, Mahfoud F, Schmid A et al. Renal denervation in moderate treatment resistant
hypertension.
J Am Coll Cardiol 2013.
Schlaich MP1, Schmieder RE, Bakris G. International expert consensus statement: Percutaneous
transluminal renal denervation for the treatment of resistant hypertension. J Am Coll Cardiol.
2013 Dec 3;62(22):2031-45.
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.136, 9/12/13
Medical Director review 4/2014
Specialty Matched Consultant Advisory Panel review 4/2014
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.136, 9/11/14
Specialty Matched Consultant Advisory Panel review 4/2015
Medical Director review 4/2015
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.136, 9/10/15
Specialty Matched Consultant Advisory Panel review 4/2016
Medical Director review 4/2016
BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.136, 9/2016
Specialty Matched Consultant Advisory Panel review 4/2017
Medical Director review 4/2017
Page 4 of 5
An Independent Licensee of the Blue Cross and Blue Shield Association
Radiofrequency Ablation of the Renal Nerves as a Treatment of
Hypertension
Policy Implementation/Update Information
10/30/12
New policy developed. Radiofrequency ablation of the renal sympathetic nerves is
considered investigational for treatment of resistant hypertension. Medical Director
review 10/2012. (mco)
5/14/13
Specialty Matched Consultant Advisory Panel review 4/2013. Medical Director review
3/2013. New product information added to Description section. References updated. (mco)
12/31/13
Deleted unlisted code 64999 and added CPT codes 0338T and 0339T to Billing/Coding
section. (mco)
5/13/14
Description section updated. References updated. Specialty Matched Consultant Advisory
Panel review 4/2014. Medical Director review 4/2014. No changes to Policy Statements.
(mco)
11/11/14
References updated. No changes to Policy Statements. (td)
5/26/15
Specialty Matched Consultant Advisory Panel review 4/2015. Medical Director review
4/2015. Policy Statements remain unchanged. (td)
10/30/15
Description section: Regulatory Status updated. Policy Guidelines section extensively
revised. References updated. (td)
5/31/16
Specialty Matched Consultant Advisory Panel review 4/27/2016. Medical Director review
4/2016. (jd)
5/26/17
References updated. Specialty Matched Consultant Advisory Panel review 4/2017.
Medical Director review 4/2017. (jd)
Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are
determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and
subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational
purposes only and is based on research of current medical literature and review of common medical practices in the treatment
and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review
and revise its medical policies periodically.
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An Independent Licensee of the Blue Cross and Blue Shield Association